Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Dhar, India | Makes it | Problems found, fixed voluntarilySep 27, 2024 · 4 inspections |
Recalls
- Jul 2, 2019 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Lots: Lot L800050
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ethinyl Estradiol and Norethindrone: every company that makes it
- Form
- kit
- Strength
- 0.8 mg / 0.025 mg
- Approval
- ANDA ANDA203448
- On the market since
- Feb 7, 2021
- Package NDCs
68180-356-7468180-358-7468180-903-73- Official label
- DailyMed (National Library of Medicine), updated Dec 2, 2025
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